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Companion Diagnostics In Oncologic Development: Idhifa And Lynparza Show Benefit Of Early Focus

Executive Summary

Pink Sheet's Drug Review Profile looks at how Celgene's Idhifa sped from IND to approval, helped by prospective integration of a companion IDH2 mutation diagnostic into the clinical trial, while AstraZeneca's Lynparza was delayed by FDA concerns over retrospective analysis using germline BRCA mutation diagnostic.

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